A sensational action by the FDA to cripple development of new weight loss drugs came
about two weeks ago. The FDA denied approval to the weight loss drug candidate Contrave,
a combination of two medications. Both of the drugs in the combination pill are presently in
use and were FDA approved decades ago for indications other then weight loss. One of the
drugs Naltrexone, is used to treat opiate drug overdoses and the other bupropion HCL is used
to treat depression. Given the long history of safety of both drugs it would seem surprising
the FDA would reject the combination of these drugs on grounds of safety concerns, which
was what happened. Making the FDA rejection even more astounding is that just a month
before, a majority of members of the FDA’s own Endocrinologic and Metabolic Drugs Advisory
Committee, gave a thumbs-up to Contrave. In almost all previous instances where the Advisory
Committee gives their green light to a new drug candidate, the FDA has followed through with
an approval. I can hardly imagine a clearer way for the FDA to say “Drop Dead!!” to all those
seeking to get approval for a new weight loss medication.

Michael Narachi, CEO of Orexigen the maker of Contrave, is quoted as saying he “was
surprised and extremely disappointed with the agency’s (FDA’s) request”, a request which
essentially ended any chance of getting approval for his company’s weight loss drug. My advice
Michael, is to move on with your company and find another drug class to work on. Maybe
something to smooth away skin wrinkles or relieve constipation. I’m sure you will have a lot
more success. In the meanwhile, the epidemic of diabetes type 2, cardiovascular disease, and
disabilities due to degenerative joint disease, all related to obesity, marches on.

A final note of advice to investors in the medical field. I would spend my money on a psychiatrist
before investing money in companies conducting research on weight loss medication, since you
won’t see a penny from your investment for ten plus years.

As a culture we don’t plan for a sudden halt in scientific advancements. Our tendency is to expect progress to be rapid and continuous. My prediction is that in certain areas of medical science we are likely to see not only a halt in progress but a slipping backward. In particular, the realm of medical weight management is in complete disarray at this time. Two new drugs designed to induce weight loss have been shot down by the FDA in the last few months. The first is Qnexa, developed by Vivus Inc. Interestingly, Qnexa combines two drugs already approved for use in the U.S. One of the drugs is phentermine which is a medication used for decades as an appetite suppressant. The other is a common drug used to treat seizures with the brand name Topamax (topiramate) which also induces weight loss. The drug performed admirably in clinical trials with most participants losing over 10% of body mass. The FDA cited excessive risks of the drug in its statement of rejection. One wonders why the drugs are still being marketed separately if they are so dangerous.

The latest drug to be rejected by the FDA is Lorgess (lorcaserin), developed by Arena Pharmaceuticals. This drug, not as effective as Qnexa, produced 5% body mass loss in about half of participants in clinical trials. Lab animals showed a tendency to develop breast tumors when exposed to the medication, adding to the FDA’s decision to reject the drug application based on safety concerns.

I am a strong advocate of drug safety and regulation. On the other hand we know obesity, and with it Type 2 diabetes, is epidemic in the U.S. I regard weight loss as the “holy grail” when treating type 2 diabetes and yet it is the most difficult goal to achieve. Any drug which could assist in weight loss is highly desirable in the treatment of Type 2 diabetes. Not only does blood sugar improve with weight loss but also blood pressure and cholesterol readings show declines. All three of these parameters are known to be prime contributors to the main cause of death in diabetics, cardiovascular disease.

It has already been 10 years since the last drug was approved specifically for a weight loss indication. The failure of these two latest medications to achieve approval is certain to cause the pharmaceutical industry to severely curtail if not abandon further investment in this type of drug development.

Why is the FDA so reluctant to approve a weight loss pill? This is a complex issue but requires an answer. A new weight loss inducing medication is certain to be highly anticipated and widely prescribed. Therefore, from the very first day of approval the FDA must take responsibility for the well being of millions of people who are likely to take the medication. We are a society which demands our medications deliver miraculous cures with no side-effects. If someone perceives they have been injured by a medication our legal system is primed to unleash brutal retribution on everyone remotely involved in the approval process. Abuse and injury with a medication designed to cause weight loss is almost a certainty. This is a no-win situation for the administration of the FDA.
I predict it will be at least another 10 years before a medication for weight loss is approved by the FDA. Unless there is a change in the climate of litigation in this country it will take longer than that. In the meantime the only new developments in weight loss drugs will be the result of exploiting appetite suppressant effects which are the “side-effect” of medications approved for other purposes.

Below, Mele describes her plight struggling to adjust to the disappearance of Armour from U.S. pharmacies. She discovered what was explained in my post, “Behind the Disappearance of Armour”. Forest Pharmaceuticals and Medicare are both responding in their own ways to the FDA decree that Armour Thyroid submit an application (NDA) as if it were any new drug seeking to come to market now. The FDA is charged with the responsibility to assure all prescription drugs in the U.S. demonstrate minimum levels of safety and efficacy. As a bureaucracy the FDA is unable (unwilling) to find a way to use the 50+ years of unblemished clinical experience unique to Armour, to satisfy this requirement. Rather than correct its own deficiency the FDA is forcing many thousands of hypothyroid patients on dessicated thyroid products to go through the difficult and potentially dangerous process of finding alternative thyroid hormone therapies. I am guessing that the FDA is receiving support for this policy from companies making synthetic t4 products and from medical organizations and their officers who receive funds from these same companies. Let’s not forget that Forest itself markets a generic t4 product, Levothroid, which will absorb some of the business lost by the withdrawal of Armour.

Mele submits her story to metabolism.com:

I’m just devastated. I could only get a seven day supply yesterday of Armour at Wal-Mart. They have no idea what the problem is and told me to come in Tuesday and they would have some again. I had no idea there was a problem again (last year’s nightmare made me assume everything would be ok after Forrest redid their manufacturinging plant) until I googled today.

I am 66 years old and have been on Armour Thyroid since I was 15 years old when I had a subtotal thyroidectomy for carcinoma. The only time I ever tried Synthroid was about 20 years ago when an endocrinologist convinced me that I was going to get osteoporosis if I continued using Armour. I only took it for two months, and when I walked into my family doctor’s office at the end of the two months, he took haveone look me and said “whWt is wrong? You are not you”. I wasn’t me anymore (and the blood tests he ordered confirmed that I was very low on T3 and barely in the normal range for T4). That was probably the most terrifying experience I have ever had. I had no idea how totally entwined my personality, and feelings of well being, are dependent on Armour. I still find it scary that “me” is a product of a drug I take and when I take a different brand, I am no longer me. I felt like a stranger in my own skin…weak, no sparkly, dramatic personality… instead dull feeling, acting and cobwebs in my brain. My family doctor said that he was putting me back on Armour immediately and slowly I began to feel like me again.

I’m terrified now. I am in the middle of trying to prepare for a very complicated (nothing is ever simple or easy medically for me) cataract surgery in another city that I have fly to repeatedly for the presurgical appointments. If I have to go on Synthyroid again…how can I deal with this other upcoming surgery? It can’t be put off as I can barely see to drive now.

Anyhow, I agree with others here that we have to organize and fight this. I find it very difficult to believe this is simply a shortage of the thyroid powder that Forrest is claiming is the problem. This is the FDA meddling, yet again, with patients very lives. I think I know an organization that will help us as they have fought bloody battles with the FDA for many years and have been victorious to a large extent. I am speaking of the Life Extension Foundation. I’ll be contacting them.

Two other things. For what it is worth, I have noticed no problems with the change in Armour but for the first time in many years, I have not done thyroid blood levels in two years. But I feel fine so I guess I don’t have the absorbtion problem some mention with the new formula. I have had hair breakage though which I have puzzled over and that could well be due to the formula change.

As for Medicare and Armour, I have had Medicare since a drunk driver hit me many years ago so I have had Medicare long before I turned 65. When Medicare Part D first appeared Armour was on the Medicare forumulary. That was in mid 2006. Armour was on the Medicare formulary in 2007 also. Beginning Jan 2008, Armour was removed from the Medicare formulary. My physician I did a lot of research, calling, letter writing, etc. about it. My drug plan was and still is from AARP/United Health Care. United Health Care is angry about the Armour situation. However, they cannot make a special exception to cover it when a physician asks them to do so (as mine did) because their hands are tied. They are required by law to allow ONLY drugs that are approved and on the Medicare formulary.

AARP/United Health Care covers ALL drugs on the Medicare formulary and by law cannot cover any that are banned from the Medicare formulary. Armour was banned in 2008. I called Forest about it and was extremely puzzled by their lacksidasical response. My physician wrote Forrest also and they sent back a reply that had nothing to do with the question about Armour being removed from the Medicare formulary. My physician learned later that his, and my, suspicions were correct. It was removed because the FDA told Medicare that they could not cover a drug that had not gone through the NDA I believe it is called…where a new drug has to undergo extensive clinical trials as per FDA regulations. We learned that the FDA was requiring Forrest to do this if they wanted Medicare coverage for Armour. Well, that is not possible. Forrest charges very little for Armour. Where are they supposed to get the money for the many years of clinical trials that the FDA has demanded? The FDA knew that demanding this would effectively kill Armour and that was their intent.

So, since Jan 2008, I have had to pay for a Medicare Part D plan that I can’t use because the only drug I take (unless I need an antibiotic or something short term) is Armour. Wat is worse, most health insurance companies follow the Medicare formulary so if Medicare no longer covers Armour then most insurance plans will not cover it either.

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Metabolism related disorders can really sneak up on you with no warning. Actually almost any disease can, the question is what you can do to prevent it or to manage it. There are many articles around how to prevent various disorders but, really, there are so many of them you don’t even want to know. Plus, it can create an anxiety to think about that. Before attending Chinese medicine school I had no idea about the variety of diseases, and at some point in the western medicine section of my education, particularly pathology, I even freaked out looking at all these scary photos. The bottom line is you never know what your genetic blueprint is exactly going to produce, what new flu is about to emerge, and which next food choice would be proved dangerous. I’m not even mentioning numerous prescription and over-the-counter drugs with various issues. However the reality, there is not so much you can do to control external environment, even by washing your hands and buying organic. Don’t take me wrong, please by all means take precautions – watch your diet, visit your doctor for regular checkups, follow the news on health and nutrition. And whatever happens – stay calm. It is your internal environment you can control to make decisions from the balanced and educated mood.

Many of us experienced scary moments when dreadful news are delivered to us and loved ones about the disease that has no cure and at the best can be managed with medications or nothing at all – just wait and see. Probably the scariest of all is placing your fate to the hands of your doctor while “googling” for hours, asking friends, pacing back and forth, screaming at heavens, feeling powerless. Then you have to make a decision – either disease has you – or – you have been diagnosed with the disease. I would strongly advocate for the second choice simply because it leaves you with the power to choose what to do from the place of your own unique constitution – on all levels. The disease never manifests exactly the same for everyone, and never can be treated exactly the same. The limitation here is what you already know vs what you don’t know yet.

The rule of thumb: never give up. The miraculous cures are recorded over and over again – while you have a hope you have a chance. Don’t believe a doctor who takes hope away from you, it is your health and your body – you have the right to press for answers, demand explanations, copies of your medical records, and consultations about other choices. Turn your attention to alternative medicine. A good medical doctor never blindly dismisses an alternative option – he will study it and give you his/her opinion. Some doctors don’t have time to educate themselves about other kinds of medicine and you can encourage them to do so. More and more medical doctors embrace acupuncture, nutrition, homeopathy, and other modalities in their practice or in collaboration with other practitioners. It all comes down to what patient will benefit from the most, and the safety of therapies integration. It is equally important to provide your alternative medicine doctor with copies of your lab results, especially if you are looking to benefit from herbal medicine or nutrition care.

We are lucky to live now – the age of technology. Modern and ancient medicines are dancing together building bridges between top-notch machines and dried herb decoctions, brain surgeries and homeopathy. Using it all you can expand your choices and the most important – build a well-defined plan to heal yourself using the expertise of doctors and specialists you trust.

Ramona has been in our thoughts and dreams for sometime now. You might say we are a little obsessed with Ramona. By Ramona I mean ramonabant, the appetite supressant which goes by the name Acomplia in Europe. We have been following the news of her arrival in the U.S. with great anticipation for the past year.

Now we have word that Ramona is changing her name to Zimulti. Zimulti does sound a bit Mediterranean and may reflect the diet pill’s origins in Europe. Why she has taken on this assumed name confuses us. What is even more disturbing is that it has been learned that Ramona, Acomplia or Zimulti is associated with a risk of suicidal thoughts in those who use this drug. Is she truly capable of driving people out of their minds?

Sources tell us that Ramona/Zimulti is headed for review by the FDA in the U.S. next month (July). As always all we can do is sit and wait for the word from above whether our dear Ramona will be headed our way soon or will become an outcast fated to languish out of reach on a distant continent.